BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 33CM L-TIP ELECTROSURGICAL PROBE (3BX)

    MDR report key: 3230495 · Received July 16, 2013

    Report

    Report Number
    0002936485-2013-00301
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    April 9, 2013
    Report Date
    June 27, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    PMA / PMN Number
    K934094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE POSSIBLE ROOT CAUSES FOR THE REPORTED FAILURE CAN BE DUE TO: USE ERROR, IMPROPER STERILIZATION AND/OR NORMAL WEAR AND TEAR. HOWEVER, THIS CANNOT BE CONFIRMED SINCE THE UNIT WAS NOT RETURNED. IN THE EVENT THAT THE UNIT IS RETURNED, A FULL EVALUATION WILL BE CONDUCTED AND A FOLLOW UP REPORT WILL BE ISSUED. IN SUM, THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON THOUGHT HE SAW A SPARK JUST PROXIMAL TO THE HOOK TIP. THE SPARK OCCURRED WHILE HOOK WAS BEING USED TO FREE THE GALLBLADDER FROM THE LIVER AND THUS WAS IN CLOSE PROXIMITY TO THE LIVER. THE DEVICE WAS REMOVED IMMEDIATELY AND THE SCRUB NURSE CONFIRMED THAT THERE WAS A DEFECT IN THE INSULATION. SURGEON INSPECTED THE LIVER BED, DUODENUM, AND COLON AND OBSERVED NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON THOUGHT HE SAW A SPARK JUST PROXIMAL TO THE HOOK TIP. THE SPARK OCCURED WHILE HOOK WAS BEING USED TO FREE THE GALLBLADDER FROM THE LIVER AND THUS WAS IN CLOSE PROXIMITY TO THE LIVER. THE DEVICE WAS REMOVED IMMEDIATELY AND THE SCRUB NURSE CONFIRMED THAT THERE WAS A DEFECT IN THE INSULATION. SURGEON INSPECTED THE LIVER BED, DOUDENUM, AND COLON AND OBSERVED NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329137 5MM, 33CM L-TIP ELECTROSURGICAL PROBE (3BX) LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1